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TAFINLAR
Melanoma and other skin cancers
Respiratory and thoracic cancers
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Drug Name:

TAFINLAR Rx

Generic Name and Formulations:
Dabrafenib 50mg, 75mg; caps.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for TAFINLAR:

As monotherapy for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test. In combination with trametinib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

Limitations Of use:

Not indicated for the treatment of wild-type BRAF melanoma.

Adult:

Confirm presence of BRAF V600E or V600K mutation prior to initiation. Swallow whole. Take at least 1hr before or 2hrs after a meal. Monotherapy or in combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new primary cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional lower limit of normal. Withhold if fever ≥101.3°F or any serious febrile reaction occurs and evaluate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 2wks after last dose. Pregnancy. Nursing mothers: not recommended (during and for 2wks after last dose).

Interactions:

Avoid concomitant strong CYP3A4 or CYP2C8 inhibitors (eg, ketoconazole, nefazodone, clarithromycin, gemfibrozil); if unavoidable, monitor closely. May antagonize effects of CYP3A4, CYP2C8, CYP2C9, CYP2C19, CYP2B6 substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives); consider alternatives or monitor.

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome; skin toxicity (may be serious). In combination with trametinib: also chills, fatigue, rash, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Caps—120

Indications for TAFINLAR:

In combination with trametinib for the treatment of metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test.

Limitations Of use:

Not indicated for the treatment of wild-type BRAF NSCLC.

Adult:

Confirm presence of BRAF V600E mutation prior to initiation. Swallow whole. Take at least 1hr before or 2hrs after a meal. Monotherapy or in combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new primary cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional lower limit of normal. Withhold if fever ≥101.3°F or any serious febrile reaction occurs and evaluate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 2wks after last dose. Pregnancy. Nursing mothers: not recommended (during and for 2wks after last dose).

Interactions:

Avoid concomitant strong CYP3A4 or CYP2C8 inhibitors (eg, ketoconazole, nefazodone, clarithromycin, gemfibrozil); if unavoidable, monitor closely. May antagonize effects of CYP3A4, CYP2C8, CYP2C9, CYP2C19, CYP2B6 substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives); consider alternatives or monitor.

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome; skin toxicity (may be serious). In combination with trametinib: also chills, fatigue, rash, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Caps—120

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